Sr. Manufacturing Engineer

Sr. Manufacturing Engineer

Sr. Manufacturing Engineer for Medtronic, Inc. located in Milwaukee, WI. Responsible for improving manufacturing processes, optimize product performance and reduce manufacturing costs. Provide manufacturing floor support and coordinate implementation of manufacturing improvements to assigned product lines. Assist with daily production and development of Class I, Class II and Class III Medical Devices by supporting machining, packaging, warehousing, and inventory control. Responsible for cleaning validations per ISO 10993 to ensure new medical devices or manufacturing changes meet biocompatibility requirements of cytotoxicity and endotoxin tests. Utilize Six Sigma tools including Good Manufacturing Practices (GMP), 5S, 6M, 5-Whys, DMAIC & Kaizen to drive process efficiency and reduce cost in the manufacturing process. Develop protocols for Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method Validations (TMV). Implement and validate new manufacturing processes including laser marking, passivation and anodization. Conduct studies pertaining to cost control, waste reduction, and inventory control and production record systems using Agile MAP. Coordinate investigation of Non-Conformances (NCs) and Corrective and Preventative Actions (CAPA) Investigations to control non confirming product and mitigate process risks or deviations that will impact patients. Navigate various engineering principles within an FDA regulated environment (FDA 21 CFR Part 820) and follow ISO-13485 and ISO 9001. Provide Design for DRM (Design, Reliability, and Manufacturing) practices and tools using Solid works or Unigraphics modeling software. Leverage knowledge from being a certified Lean Sigma Yellow belt or higher. Relocation assistance not provided.

Other Experience and Qualifications: Requirements: Bachelor\'s degree in Mechanical, Industrial, Biomedical, Electronics Engineering or related engineering field and five (5) years of experience as manufacturing or quality engineer. Or, Master\'s degree in Mechanical, Industrial, Biomedical, Electronics Engineering or related engineering field and two (2) years of experience as manufacturing or quality engineer. Specific skills and other requirements: Must possess at least two (2) years\' experience with each of the following: Manufacturing in medical device industry including Class I, Class II and Class III devices; Cleaning validations per ISO 10993 & Cytotoxicity and Endotoxin testing; Six Sigma methodologies including GMP, 5S, 6M, 5-Whys, DMAIC, & Kaizen; IQ/OQ/PQ, TMV, & Gage R&R Laser marking technology, Passivation, and Anodizing process; Coordinating studies for cost control, waste reduction and inventory control; NC & CAPA Investigations; Medical Device Quality & Regulatory Compliance (FDA 21 CFR Part 820, ISO 13485, and ISO 9001); DRM practices and tools using Solid works or Unigraphics modeling software.